DelfaGLP-1 Atlas

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TEACH

Not yet recruitingPhase 4

Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

0

Recruiting sites

—

Enrollment

30

estimated

Study population

Cardiovascular disease, Obesity / overweight

Key I/E criterion

—

Primary endpoints

•Exercise capacity after 6 months of treatment with tirzepatide•Left ventricular systolic function after 6 months of treatment with tirzepatide•Total cholesterol, change

Identifiers

Registered as

NCT IDNCT07354880
Org study ID0120-156/2025-2711-4

Timeline

Milestones

Study start2026-01-20estimated
Study first posted2026-01-21actual
Last update posted2026-01-21actual
Primary completion2027-06-30estimated
Study completion2027-12-31estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Cardiovascular diseaseObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Obese or overweight adult patients with congenital heart disease
•BMI between 30 kg/m² and 40 kg/m²
•Prior comprehensive non-pharmacological and non-surgical management of obesity, including a history of at least 12 months of intensive lifestyle intervention with a maximum weight reduction of less than 5%
•Stable body weight within the three months preceding study enrollment (defined as weight fluctuations within 5%)
•No prior pharmacological or surgical interventions for obesity
•Euthyroid state
•Eumenorrhea or oligomenorrhea
•Ability to comprehend the study objectives and procedures
•Willingness to provide informed consent and to comply with the study protocol, including the use of highly effective contraception during the study period, with signed consent and agreement provided in duplicate
•Commitment to use highly reliable contraception and absence of plans for pregnancy within the 8 months following enrollment.

Exclusion criteria

•Down syndrome
•Type 2 diabetes
•Severe heart failure (NYHA IV), EF of systemic or subpulmonary ventricle < 30%, malignant arrhythmias, severe heart valve disease
•Personal history of malignancy, personal or family history of medullary thyroid carcinoma
•Personal history of pancreatitis or cholelithiasis
•Personal history of acute coronary events or hemodynamically significant coronary artery disease
•Current treatment with sympathomimetics or sympatholytic
•Psychiatric disorders, personal history of depressive disorders or suicidal ideation
•Pregnancy or lactation, postmenopausal, amenorrhea, reliance on natural contraception methods
•Excessive alcohol consumption
•Smoking

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers
3
Patient-reported / QoL
2
Weight & body composition
1
Heart failure
1
Other clinical outcomes
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change in body weight after 6 months of treatment with tirzepatide.

Time frame:From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

Body weight, absolute change (kg)

change from baseline, improvement

Heart failure

1 endpoint
Primary/protocol endpoint

Change in exercise capacity after 6 months of treatment with tirzepatide.

Time frame:From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Primary/protocol endpoint

Change in cholesterol levels after 6 months of treatment with tirzepatide.

Time frame:From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in endothelial function after 6 months of treatment with tirzepatide.

Time frame:From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

change from baseline, improvement

Secondary/protocol endpoint

Change in arterial stiffness after 6 months of treatment with tirzepatide.

Time frame:From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Other/protocol endpoint

Change of quality of life after 6 months of treatment with tirzepatide.

Time frame:From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

SF-36 total

change from baseline, improvement

Other/protocol endpoint

Change of anxiety and depression after 6 months of treatment with tirzepatide.

Time frame:From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

change from baseline, improvement

Other clinical outcomes

1 endpoint
Other/protocol endpoint/low confidence

Change of physical activity after 6 months of treatment with tirzepatide.

Time frame:From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Change in left ventricular systolic function after 6 months of treatment with tirzepatide.

Time frame:From enrollment (visit 1) to the end of the treatment at 6 months (visit 6).

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.